Lifestyle Intervention in Primary Health Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2006-03-31

Brief Summary

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The purpose of this study is to determine whether a short group intervention programe aiming at lifestyle changes at a local health centre can improve risk factors for cardiovascular disease

Detailed Description

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Successfully transferring the findings of expensive and tightly controlled lifestyle intervention programmes to the primary care setting is necessary if such knowledge is to be used for disease prevention at the population level. Therefore, our objective was to evaluate the efficacy of a lifestyle intervention programe in the primary health care setting, targeted at patients with moderate- to high-risk of cardiovascular disease according to cardiovascular risk factor levels, physical activity and quality of life ratings.

Randomised controlled trial with follow-up at 3, 12, 24 and 36 months, carried out in a primary health care centre in Northern Sweden. A total of 151 middle-aged men and women, with hypertension, dyslipidemia, type 2 diabetes or obesity were enrolled. The subjects were randomised to an intervention (n = 75) or control group (n = 76). 120 subjects completed the three-year follow-up. The intervention was based on the protocols used in the Finnish Diabetes Prevention study (DPS) and the U.S Diabetes Prevention Program

Conditions

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Hypertension Type 2 Diabetes Obesity Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Exercise and diet - based on DPS and DPP

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients from one single health care centre with a diagnosis of:

* Typ 2 diabetes,
* Hypertension,
* Obesity or
* Dyslipidemia

Exclusion Criteria

* Coronary heart
* Disease,
* Stroke,
* TIA,
* BP \>180/105,
* Dementia; or
* Severe psychiatric disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Mats CE Eliasson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University, Umeå, Sweden

Locations

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Björknäs Health Centre

Boden, , Sweden

Site Status

Countries

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Sweden

References

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Eriksson KM, Westborg CJ, Eliasson MC. A randomized trial of lifestyle intervention in primary healthcare for the modification of cardiovascular risk factors. Scand J Public Health. 2006;34(5):453-61. doi: 10.1080/14034940500489826.

Reference Type RESULT

PMID: 16990155 (View on PubMed)

Eriksson MK, Hagberg L, Lindholm L, Malmgren-Olsson EB, Osterlind J, Eliasson M. Quality of life and cost-effectiveness of a 3-year trial of lifestyle intervention in primary health care. Arch Intern Med. 2010 Sep 13;170(16):1470-9. doi: 10.1001/archinternmed.2010.301.

Reference Type DERIVED

PMID: 20837834 (View on PubMed)

Eriksson MK, Franks PW, Eliasson M. A 3-year randomized trial of lifestyle intervention for cardiovascular risk reduction in the primary care setting: the Swedish Bjorknas study. PLoS One. 2009;4(4):e5195. doi: 10.1371/journal.pone.0005195. Epub 2009 Apr 14.

Reference Type DERIVED

PMID: 19365563 (View on PubMed)

Other Identifiers

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EPN-Umea 02-512

Identifier Type: -

Identifier Source: org_study_id

Lifestyle Intervention in Primary Health Care - the Björknäs Study